Effects of Coca-Cola Zero Sugar Consumption on Urinary Metabolites in Healthy Adults

NCT07694401 | Completed

• 1 other identifier: 155/23 S-IV
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Consumption of beverages containing non-nutritive sweeteners has increased worldwide, but limited information is available regarding the short-term urinary excretion of acesulfame potassium (Ace-K) and the acute metabolic response following consumption of commercially available beverages. This study investigates the urinary pharmacokinetics of Ace-K and the acute urinary metabolomic response after consumption of 500 mL of Coca-Cola Zero Sugar in healthy adults. Participants complete two study arms under free-living conditions: Coca-Cola Zero Sugar and still water (control), separated by a one-month washout period. Urine samples are collected before beverage consumption and repeatedly over the subsequent 24 hours. Proton nuclear magnetic resonance (¹H NMR) spectroscopy is used to quantify Ace-K and other urinary metabolites. The study aims to determine the urinary appearance and elimination kinetics of Ace-K and to identify metabolic changes associated with Coca-Cola Zero Sugar consumption compared with water.

Conditions

Healthy Adult Participants

Keywords

Non-nutritive sweeteners; Acesulfame potassium; Proton NMR spectroscopy; Urinary metabolomics

Outcome Measures

Primary Outcomes (1)

• Creatinine-normalized urinary acesulfame potassium (Ace-K) concentration (µM/mM creatinine)

  Quantitative measurement of urinary acesulfame potassium (Ace-K) concentration following consumption of 500 mL Coca-Cola Zero Sugar and still water, determined by quantitative proton nuclear magnetic resonance (¹H NMR) spectroscopy. Concentrations will be normalized to urinary creatinine and reported at each scheduled urine collection time point.

  Baseline and each scheduled urine collection over 24 hours following beverage consumption.

Secondary Outcomes (1)

• Creatinine-normalized urinary metabolite concentrations (µM/mM creatinine)

  Baseline and each scheduled urine collection over 24 hours following beverage consumption.

Other Outcomes (2)

• Area under the urinary acesulfame potassium concentration-time curve (AUC₀-₂₄)

  Up to 24 hours after beverage consumption

• Concentrations of selected constituents in Coca-Cola Zero Sugar (µg/mL)

  Prior to participant consumption (baseline beverage characterization)

Study Arms (2)

Coca-Cola Zero Sugar

EXPERIMENTAL

Participants consumed 500 mL of Coca-Cola Zero Sugar with breakfast. Spot urine samples were collected before beverage consumption and repeatedly over the subsequent 24-hour period for metabolomic and pharmacokinetic analyses using proton nuclear magnetic resonance (¹H NMR) spectroscopy.

Other: Coca-Cola Zero Sugar

Still Water

ACTIVE COMPARATOR

Participants consumed 500 mL of still water with breakfast following a one-month washout period. Spot urine samples were collected before beverage consumption and repeatedly over the subsequent 24-hour period using the same sampling schedule as the Coca-Cola Zero Sugar arm.

Other: Still water

Interventions

Coca-Cola Zero Sugar OTHER

Participants consumed a single oral dose of 500 mL Coca-Cola Zero Sugar with breakfast. The intervention beverage was consumed within approximately 10-20 minutes. Spot urine samples were collected before consumption and repeatedly over the subsequent 24-hour period for metabolomic and pharmacokinetic analyses using proton nuclear magnetic resonance (¹H NMR) spectroscopy.

Also known as: Coke Zero

Coca-Cola Zero Sugar

Still water OTHER

Participants consumed a single oral dose of 500 mL still water with breakfast under otherwise comparable conditions following a one-month washout period. Spot urine samples were collected before consumption and repeatedly over the subsequent 24-hour period using the same sampling schedule as the intervention arm.

Also known as: Control

Still Water

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults aged 18 to 60 years
• Able and willing to provide written informed consent
• Willing to consume 500 mL of Coca-Cola Zero Sugar and 500 mL of still water during separate study periods
• Willing to collect urine samples before and during the 24 hours after each intervention according to the study instructions
• Willing to avoid foods and beverages containing non-nutritive sweeteners for 48 hours before each study period

You may not qualify if:

• Younger than 18 years or older than 60 years
• Current smoker
• Known kidney disease or metabolic disease
• Regular use of prescription medications
• Use of antibiotics in last 3 months
• Consumption of foods or beverages containing non-nutritive sweeteners within 48 hours before either study period
• Unable or unwilling to comply with the study procedures or urine collection schedule

Sponsors & Collaborators

• Czech University of Life Sciences Prague: lead

Study Sites (1)

Czech University of Life Sciences Prague

Suchdol, Prague, 16500, Czechia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: All participants completed both interventions in a fixed order separated by a one-month washout period. Coca-Cola Zero Sugar was administered first, followed by still water, with each participant serving as their own control. The order of arms was not randomized; all donors completed the treatment arm first, followed by the control arm after the washout period

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 10, 2026
• Study Start: September 1, 2023
• Primary Completion: June 15, 2024
• Study Completion: September 30, 2024
• Last Updated: July 23, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)